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In fact, by 2011, prescription drugs accounted for nearly 10% of national health-related spending in the United States.(1) A study published in the Journal of the American Medical Association found that by 2012, nearly three in every five American adults had taken a prescription drug sometime in the previous month.(2)
New drugs can bring new risks for people who take them. Adverse drug events (ADEs) can lead to serious medical complications or death.
Estimates of how many people experience adverse drug events vary widely. The U.S. Department of Health and Human Services (HHS) has estimated adverse drug events are responsible for approximately 280,000 hospital admissions annually in the U.S.(3) The Institute for Safe Medication Practices (ISMP) has estimated that adverse drug events may have been responsible for between two and four million “serious, disabling, or fatal” injuries — including 128,000 patient deaths — in 2011.(4)
New drugs must be approved by the U.S. Food & Drug Administration (FDA) before they are sold. However, problems may still occur any time — before, during, or after the approval process. In fact, in recent years, several drugs have been linked with serious medical complications.
|Proton Pump Inhibitors (Nexium, Prilosec)|
|Fluoroquinolone Antibiotics (Cipro, Avelox)|
|Testosterone Replacement Therapy drugs (AndroGel, Fortesta)|
If you suffered severe complications or were hospitalized due to an adverse drug event, or if a relative died due to prescription drug-related complications, you may want to discuss your legal options with a knowledgeable attorney.
Weitz & Luxenberg may be able to help. We invite you to call us for a free consultation (855) 274-5624.
Consult your doctor before stopping any prescribed medication.
How Are Drugs Approved?
In 1938, Congress enacted the Food, Drug, and Cosmetic (FDC) Act. Since then, the drug approval process has continued to evolve.
In 1962, a sleeping pill called thalidomide, not approved for use in the U.S. due to efforts taken by Dr. Frances Kelsey at the FDA, resulted in thousands of babies being born with birth defects in Western Europe after their mothers had taken the drug during pregnancy. In response, Congress approved legislation requiring drug manufacturers to demonstrate to the FDA that any new drug is safe and effective for its intended use before selling it in the U.S.(5)
To secure FDA approval, drug manufacturers must conduct limited laboratory, animal, and clinical tests to determine how new drugs work and whether they are safe for use in humans.
A team at the FDA’s Center for Drug Evaluation and Research (CDER) composed of doctors, chemists, and other scientists reviews the evidence from these limited tests. If this group of FDA employees determines results presented from this testing demonstrate a level of safety and a measurable health benefit, the FDA may approve the drug.(6) In some cases, especially for particular classes of drugs, the FDA may approve a drug with the stipulation that additional postmarketing testing be conducted or that postmarketing safety monitoring of particular adverse events be performed by the manufacturer.(7) (8)
Potential Risks from New Drugs
Sometimes the tests do not reveal all the potential risks of a new drug. In addition, in some cases, drug manufacturers fail to present all their evidence, submit erroneous or falsified information, fail to report adverse events or other study protocol violations, or fail to protect the safety of clinical trial patients.(9)
In addition, drug manufacturers may not communicate the risks of a drug to the public, even if the FDA discovers a problem at a clinical trial site during an inspection or after a medical journal publishes the results of a clinical trial. In fact, sometimes the problems can be substantial enough to cause or contribute to serious medical complications or even death.
Somewhere down the line, the FDA may require updated label instructions or warnings for complications, but, by then, the damage may have already been done. For some patients, the warning may come too late.
Adverse effects of medicines have spawned thousands of lawsuits in recent years.
PPIs (Proton Pump Inhibitors)
Proton pump inhibitors (PPIs) are some of the most popular heartburn medications on the market. Drugs in this class include:
- Nexium (esomeprazole)
- Prilosec (omeprazole)
- Prevacid (lansoprazole)
- Dexilant (dexlansoprazole)
- Protonix (pantoprazole)
Over-the-counter versions of PPIs include Prilosec OTC, Nexium 24HR and Prevacid 24HR. Prevacid, Prilosec, Nexium, and Protonix are also approved for use in children of specific ages.(21)
Several studies have found increased risk or incidence of serious kidney conditions in patients who have been exposed to PPIs — kidney conditions that may require dialysis or result in death. These include:
- Chronic kidney disease (CKD)(22) (23)
- Acute kidney injury (AKI)(24) (25)
- Acute interstitial nephritis (AIN)(26) (27)
- End-stage renal disease (ESRD)(28)
If you were diagnosed with any of these kidney injuries, or a relative died because of any of these conditions after taking a PPI, you may be able to seek compensation for your injuries.
By May 2017, Weitz & Luxenberg Practice Group Co-Chair Paul Pennock estimated more than 5,000 potential lawsuits across the U.S. were being considered due to the adverse effects of PPIs on kidneys. Weitz & Luxenberg alone is investigating approximately 3,500 cases. The claims involve kidney damage that is alleged to have developed from PPIs.(29) (30)
Nationwide, Paul Pennock noted roughly “122 suits have been filed, against AstraZeneca and other PPI makers such as Takeda Pharmaceuticals, Pfizer, and Procter & Gamble, which produces over-the-counter Prilosec.”(31)
Millions of Americans have taken fluoroquinolone antibiotics for bacterial infections, but in 2016 the FDA warned doctors to avoid prescribing them for certain urinary tract and respiratory infections. The agency determined the risks of serious side effects “generally outweigh the benefits for [these] patients …”(32)
Drugs in this class include:
- Avelox (moxifloxiacin)
- Cipro (ciprofloxacin)
- Cipro XR (ciprofloxacin)
- Factive (gemifloxacin)
- Floxin (ofloxacin)
- Levaquin (levofloxacin)
- Maxaquin (lomefloxacin)
- Noroxin (norfloxacin)
- Proquin XR (ciprofloxacin)
- Zagam (sparfloxacin)
The FDA has warned of potentially permanent side effects linked with fluoroquinolone antibiotics. In addition, studies have found increased risk of aortic aneurysms or dissections in patients taking fluoroquinolone antibiotics(33) (34) — conditions that can be life-threatening.(35) (36)
Testosterone Replacement Therapy (TRT) Drugs
Drugs prescribed for testosterone replacement therapy (TRT) have been heavily marketed to treat “low testosterone,” or “Low T.” Multiple studies and reports have linked the use of these prescription drugs with significant increases in the risk of potentially serious and life-threatening cardiovascular complications.(37) (38) (39)
Some common brands of TRT drugs include:
In March 2015, the FDA required TRT drug manufacturers to warn patients of a potential increased risk of heart attack and stroke with testosterone prescription drugs. Less than a year earlier, the FDA had already added a warning to testosterone product labeling regarding the risk of blood clots in veins (venous thromboembolism), including deep vein thrombosis (DVT) and pulmonary embolism (PE), with use of prescription testosterone drugs.(40) (41)
The agency also cautioned against using the drugs to treat declining testosterone levels related to aging, noting testosterone replacement therapy is only indicated for “men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.” The FDA noted in its safety announcement it had “become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.” (42)
The FDA has noted abuse of testosterone, “usually at doses higher than those typically prescribed,” which can result in:(43)
- Heart attack or failure
- Liver toxicity
- Male infertility
As of early 2017, there were more than 6,000 lawsuits against makers of TRT drugs combined into a multidistrict litigation (MDL).(44) Plaintiffs claim they suffered heart attacks, strokes, deep vein thromboses, or pulmonary emboli after using the drugs.(45)
How Weitz & Luxenberg Can Help
For more than 30 years, Weitz & Luxenberg has been at the forefront of complex product liability-related litigation. Our attorneys have secured more than $17 billion in awards and settlements for clients.
Although past results are no guarantee of future success, Weitz & Luxenberg possesses the experience and resources necessary to pursue justice for clients harmed by the negligence of large drug companies.
If you have been injured by a defective drug, we can help you understand your legal options, beginning with a free consultation. Call us at (855) 274-5624 or fill out the form on this page. One of our representatives will be in touch with you shortly.